Trial record 6 of 62 for:
"Systemic mastocytosis"
Use of Tamoxifen in Systemic Mastocytosis
This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01334996
First received: December 25, 2007
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic agent, to improve quality of life, biochemical parameters, and bone marrow involvement in systemic mastocytosis patients having 1) up to 20% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.
| Condition |
|---|
|
Systemic Mastocytosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Treatment of Systemic Mastocytosis With Tamoxifen |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype. [ Time Frame: 1 year ] [ Designated as safety issue: No ]up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 20 mg/day and the duration of treatment will be for one year.
Secondary Outcome Measures:
- Stability or improvement in biochemical markers of systemic mastocytosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]Stability or improvement in biochemical markers of systemic mastocytosis (serum tryptase, calcitonin, urinary N-methyl histamine and prostaglandin F2 excretion/24 hours, liver function studies, lactic dehydrogenase, complete blood count with leukocyte differential)
| Estimated Enrollment: | 6 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Not desired
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with systemic mastocytosis having up to 20% bone marrow involvement or clinical symptoms not controlled on current medications.
Criteria
Inclusion Criteria:
- Systemic Mastocytosis
Exclusion Criteria:
- Current treatment with Imatinib mesylate, cladribine or interferon alpha.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334996
Contacts
| Contact: Joseph H Butterfield, MD | 507-284-9077 | butterfield.joseph@mayo.edu |
Locations
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55901 | |
| Contact: Joseph H Butterfield, MD 507-284-3783 butterfield.joseph@mayo.edu | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Joseph H Butterfield, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Joseph Butterfield M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01334996 History of Changes |
| Other Study ID Numbers: | 2506-04 |
| Study First Received: | December 25, 2007 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Mastocytosis Urticaria Pigmentosa Mastocytoma Mastocytosis, Systemic Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Skin Diseases Mastocytosis, Cutaneous Pigmentation Disorders Tamoxifen |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013